Central Clinical Data Coordinator

Karachi, Pakistan
Contracted
Central Services - Clinical Data
Entry Level
Central Clinical Data Coordinator

A Central Clinical Data Coordinator works to coordinate and implement data collection for various studies, focusing on the day-to-day operations, including, monitoring the completion of project-related tasks, maintaining study-related procedures to ensure protocol and regulatory compliance. In a centralized role, the CCDC may be working on multiple trials at once, completing data capture, eDiary, and other data-related tasks.


DUTIES & RESPONSIBILITIES
  • Collect, enter, analyze, and manage data from clinical studies
  • Maintain training and understanding of FDA, GCP, GDP, IATA, and Sponsor specified systems/processes
  • Maintain working knowledge of current FDA GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
  • Ensure the quality of data submitted from assigned study sight, while, assuring timely entry into corresponding study database, submission of data and appropriate reporting and follow-up of data collection
  • Ensure the internal processes follow the study protocol, amendment(s), while being in line with
  • GCP, GDP and regulatory guidelines
  • Ensure data collected is accurate, legible, contemporaneous, original, authentic, and complete
  • Resolve any discrepancies, queries and events in-line with company and study protocols
  • Complete eDiary functions
  • Document clinical trial progress to ensure completeness of documentation and adherence to trial and/or project timelines
  • Contribute to, and/or generate requested reports for management
  • Be accountable for data collection process
  • Participate in required trainings as set forth by the company, department, sponsors, and trials
  • Being prepared for and available at all the necessary company meetings and monitoring visits for their assigned protocols
  • Submitting required administrative paperwork per company timelines
  • Any other matters as assigned by management related to data collection for responsible trials

KNOWLEDGE & EXPERIENCE

Education:
  • High school diploma required
  • Associate degree or Bachelor’s preferred
  • Experience:
  • Experience with medical terminology is a plus
  • Experience with data entry is a plus
Credentials:
  • N/A
Knowledge and Skills:
  • Strong knowledge of Google Suite products, Clinical Databases and other computer-related software
  • Excellent oral and written communication skills
  • Excellent planning and organizational skills with effective time management
  • Excellent interpersonal skills
  • Meticulous, independent, and capable of working with minimal supervision
  • Excellent data handling and analyzing skills
  • Initiative and problem-solving skills
  • Thorough understanding of clinical research principles and processes. Ability to input into process initiatives, and procedures related to Good Clinical Practices (GCP).
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